The purpose of this rule is to provide information to apply for a Biomedical Research Grant, pursuant to the provisions of Sections 215.5602 and 381.922, Florida Statutes.

DEPARTMENT OF HEALTH
Office of Statewide Research

RULE NO: RULE TITLE
64H-1.002: Biomedical Research Grant Applications
PURPOSE AND EFFECT: The purpose of this rule is to provide information to apply for a Biomedical Research Grant, pursuant to the provisions of Sections 215.5602 and 381.922, Florida Statutes.
SUMMARY: This rule provides information on how to apply for grant funding through the James & Esther King Biomedical Research Program and the Bankhead-Coley Cancer Research Program.
SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS: No Statement of Estimated Regulatory Cost was prepared.
Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.
SPECIFIC AUTHORITY: 215.5602(9) FS.
LAW IMPLEMENTED: 215.5602(5), 381.922(3)(a) FS.
IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN FAW.
THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Susan Phillips, Office of Public Health Research, Department of Health, 4052 Bald Cypress Way, Mail Bin #A24, Tallahassee, FL 32399, [phone]

THE FULL TEXT OF THE PROPOSED RULE IS:

64H-1.002 Biomedical Research Grant Applications.

(1) Grant Applications.

(a) The Florida Department of Health (Department) will accept grant applications for research initiatives into the prevention, diagnosis, treatment, and cure of tobacco-related diseases to be funded by the James and Esther King Biomedical Research Program (Program) and for research initiatives into the prevention, diagnosis, treatment, and cure of cancer to be funded by the Bankhead-Coley Cancer Research Program (Program) in response to Calls for Grant Applications (Calls).

(b) The Calls will be announced and available at the Program’s website (www.floridabiomed.com) and applications will be submitted through a web-based electronic system in a format determined by the Department.

(c) The Department may modify the format and content requirements for the Calls at any time. Notice of the modification will be announced at the Program’s website.

(d) Applicants shall not initiate contact with Biomedical Research Advisory Council members regarding the status, substance, or preparation of a grant application.

(2) Conflicts of Interest.

(a) Biomedical Research Advisory Council members are prohibited from attempting to use their council position to influence a decision to recommend an award or contract to the entities or persons with which the council member has a conflict of interest as defined in Section 112.312(8), Florida Statute.

(b) Nothing in this rule prohibits the Department or the Biomedical Research Advisory Council from adopting additional standards and reporting requirements relating to prohibited conflicts of interest that may be more rigorous than set forth in Florida Statute. Council members must comply with additional standards upon adoption.

(3) Peer Review Process.

(a) The Department will endeavor to ensure that projects representing the best science are funded. This will be accomplished through a rigorous scientific peer review process of grant applications in coordination with the Biomedical Research Advisory Council and the State Surgeon General.

(b) Scientific peer reviewers will be located outside of Florida, must disclose all conflicts of interest, and will receive an honorarium.

(c) In addition to scientific merit scores, peer reviewers will assign a tobacco-relatedness score for the James and Esther King Biomedical Research Program and a cancer-relatedness score for the Bankhead-Coley Cancer Research Program. To the extent possible, priority for funding grant applications will be given to proposals with better relatedness scores.

(4) Grant Terms and Conditions.

(a) Grant recipients must sign a Grant Terms and Conditions document. A sample document is included with each Call.

(b) Grant recipients are under a continuing obligation to notify the Program of any adverse conditions that materially impact milestones and objectives included in the research proposal and Grant Terms and Conditions.

(c) Grant funds may not be used for purposes other than those for which the grant was awarded.

(5) Termination of Grants.

(a) The Program may terminate grants prior to the expiration of the terms and conditions.

(b) The Program will notify the grant recipient in writing of the intent to terminate funding.

Rulemaking Authority 215.5602(9) FS. Law Implemented 215.5602(5), 381.922(3)(a) FS. History–New________.

NAME OF PERSON ORIGINATING PROPOSED RULE: Susan Phillips
NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Ana M. Viamonte Ros, M.D. M.P.H.
DATE PROPOSED RULE APPROVED BY AGENCY HEAD: February 5, 2010
DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAW: January 8, 2010